ZIROX— 510(k) K092630

Substantially Equivalent

Zencera, Inc.

FDA 510(k) clearance K092630 for ZIROX, Substantially Equivalent on 2009-10-22. Applicant: Zencera, Inc.. Device class: 2.

Clearance details

Applicant: Zencera, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2009-08-27
Decision date: 2009-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.